§ 271(e)(1) Pprovides a Wide Berth for the Use of Patented Inventions in Activities Related to the Federal Regulatory Process

Posted on March 25, 2024 by bwheelock

In Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd., [2022-1877] (Fed. Cir. 2024), the Federal Circuit affirmed the district court’s summary judgment that Meril’s act of importation of the two transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1).

The Federal Circuit concluded that the undisputed evidence showed Meril’s importation of the two transcatheter heart valve systems was reasonably related to submitting information to the United States Food and Drug Administration, and affirmed the district court’s
summary judgment of noninfringement.

Section 271(e)(1) sets forth:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .

This safe harbor “provides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process.” Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193, 202 (2005). As the Supreme Court in Merck explained, “it [is] apparent from the statutory text that § 271(e)(1)’s exemption from infringement extends to all uses of patented
inventions that are reasonably related to the development and submission of any information under the Food, Drug, and Cosmetic Act].” Moreover, the § 271(e)(1) exemption is not limited temporally. Mooring in the safe harbor is available to defendants irrespective of
the stage of research and even if the information is never ultimately submitted to the FDA.

St. Patrick’s Day 2024

Posted on March 15, 2024 by bwheelock

No holiday escapes the beneficial attention of inventors many of whom have sought to improve our St Patrick’s day.

U.S. Patent No. 962872 on perfume tablets designed to be dissolved in water and to give forth a perfume upon dissolution, and includes an embodiment with a shamrock design “peculiarly appropriate to dinners given on St. Patrick’s Day.”

U.S. Patent No. 5,184,482 dislcloses an ear ornament with an embodiment having a shamrock, perfect for St. Patrick’s Day:

U.S. Patent No. 5,255,825 discloses a device to “dispense green dye into individual glasses or pitchers on Saint Patrick’s Day”:

U.S. Patent No. 5,487,924 discloses napkin rings, with an embodiment perfect for St. Patrick’s Day:

U.S. Patent No. 5,491,617 discloses an Illuminated Fluid Tap, and suggests that the tap be illuminated “green for St. Patrick’s Day celebrations.”

U.S. Patent No. 5,543,321 disclosed colored plant culture media, and suggest that the media “sold at St. Patrick’s Day can contain culture medium dyed green.”

U.S. Patent No. 9,863,641, disclosed a heating appliance with light and sound that can be illuminated green for St. Patrick’s Day:

U.S. Patent No. D828774 discloses a Necklace perfect for St. Patrick’s Day:

U.S. Patent No. D828,776 discloses another embodiment of necklace perfect for St. Patrick’s Day:

Oscar Night

Posted on March 10, 2024 by bwheelock

March 10, 2024, is Oscar night, and it is difficult to think of an event that is more steeped in Intellectual Property. The Oscar statue was copyrighted (Reg. No. G38512):

and renewed (Reg. No. R443432):

The Oscar statute is also registered as a trademark (Reg.Nos. 1028635 and 1960182):

Patents, however, are connected to the Oscars in a peculiar way: a number of Oscar nominees and winners appear in patent drawings. For example, 1993 Best Supporting Actress Marisa Tomei appears in Fig. 2B of U.S. Patent No. 8,208,764:

Elizabeth Taylor, who won the Oscar for Best Actress in 1961 and 1967, is in Fig. 2C of U.S. Patent No. 8,208,764:

2018 Best Actor Nominee Timothee Chalamet and 2009 Best Supporting Actor Nominee Josh Brolin appear in Fig. 1 of U.S. Application US 20220277458:

The director of the 1980 Academy Awards Best Foreign Language Film The Tin Drum, Volker Schlöndorff, is shown in Fig. 7 of US 20220277458:

1969 Academy Award Best Supporting Actor Nominee Elliott Gould and 1984 Academy Award Best Actress Shirely McClaine are shown in Fig. 8 of US 20220277458:

Inartful Does Not Mean Indefinite

Posted on March 6, 2024 by bwheelock

In Maxell, Ltd. v. Amperex Technology Limited, [2023-1194] (Fed. Cir. 2024), the Federal Circuit reversed the finding of indefiniteness of the claims of U.S. Patent No. 9,077,035 were not indefinite.

The ’035 patent, titled “Nonaqueous Secondary Battery and Method of Using the Same,” describes and claims a lithium-ion battery with a positive electrode, a negative electrode, and a nonaqueous electrolyte. Claim 1 contained the limitation “wherein M1 represents at least one transition metal element selected from Co, Ni and Mn,” and further “wherein the content of Co in the transition metal M1 of the formulae (1) and (2) is from 30% by mole to 100% by mole,”

The district court found the claims invalid for indefiniteness, noting t reasoned that “the
plain language of the claim recites a contradiction, ”because the first limitation does not require the presence of cobalt (nickel or manganese suffices), so cobalt is “optional,”
whereas the second limitation does require cobalt.”

The Federal Circuit concluded that the district court’s rationale, was incorrect, but
not because a contradiction in a claim cannot produce indefiniteness. Rather, there is no contradiction in the claim language at issue in this case. The Federal Circuit explained:

The first of the two limitations at issue regarding M1– limitation [c]—states one requirement a transition metal element must meet to come within the claim: It must contain cobalt, nickel, or manganese. The second limitation at issue—limitation [f]—states a second requirement: The transition metal element must contain cobalt at a content of 30% to 100% by mole. It is perfectly possible for a transition metal element to meet both requirements. The two
limitations are therefore not contradictory. It makes no difference, at least here, that the two requirements are placed in separate limitations—rather than both appearing in limitation [c]. Such placement does not alter the logical point that it is possible to meet both requirements, meaning that there is no contradiction.

The Federal Circuit said that placement of the two requirements does not create an otherwise-nonexistent contradiction. That is so even if there was a more artful way of stating the two requirements within the same claim. And the record provides a readily discernible explanation for the placement: The second requirement for the M1 term was added during
prosecution to overcome a prior art reference that primarily used nickel as a transition metal. That there were other ways of drafting the claim does not render the claim language contradictory or indefinite.

Optimization Analysis Generally Requires Consideration of Whether a Person of Ordinary Skill in the Art Would have been Motivated, with a Reasonable Expectation of Success

Posted on March 5, 2024 by bwheelock

In Pfizer Inc. v. Sanofi Pasteur Inc., [2019-1871, 2019-1873, 2019-1875, 2019-1876, 2019-2224] (Fed. Cir. 2024), the Federal Circuit affirmed the Board’s conclusions
that claims 1–45 of U.S. Patent 9,492,559 are unpatentable, and the Board’s denial of Pfizer’s motions add certain claims, and vacated the denial as to certain other claims.

The ‘559 patent is directed to immunogenic compositions comprising conjugated Streptococcus pneumoniae capsular saccharide antigens (i.e., glycoconjugates)
for use in pneumococcal vaccines. Across five IPR’s the validity of all the claims was challenged.

Pfizer first contends that the Board erred in applying the “result-effective variable doctrine,” arguing that it is only appropriate in circumstances where there is actual overlap between a range in the prior art and a claimed range. Since the asserted prior art did not disclose a particular molecular weight range, there could be no presumption of obviousness, and it was
error for the Board to consider whether that variable was result-effective.

The Federal Circuit disagreed, saying that the determination whether or not a claimed parameter is a result-effective variable is merely one aspect of a broader routine optimization analysis. That analysis is rooted in the decades-old legal principle that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”

The Federal Circuit said that a routine optimization analysis generally requires consideration whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention. Where that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is “normally obvious.” The Federal Circuit found substantial evidence supported the Board’s conclusion that the varlaibe (molecular weight) would have been obvious over the references.

The Federal Circuit rejected the suggestion that unpredictability of the art affected its analysis, nothing that it has previously explained that “a rule of law equating unpredictability to patentability . . . . cannot be the proper standard since the expectation of success need
only be reasonable, not absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007)(“[O] bviousness cannot be avoided simply by a showing of some degree of unpredictability in the art so long as there was a reasonable probability of success”).

Federal Circuit Agrees that “The Invention” is the invention

Posted on March 5, 2024 by bwheelock

In Chewy, Inc. v. International Business Machines Corp., [2022-1756] (Fed. Cir. 2024), the Federal Circuit affirmed in part. reversed in part, and remanded the distirct court’s summary judgment of non-infringement of claims of U.S. Patent No. 7,072,849, and summary judgment that claims of U.S. Patent No. 7,076,443 were directed to ineligible subject matter.

Non-Infringement of U.S. Patent No. 7,072,849

Claim 1 of the ‘849 patent stated:

Infringement of the claims ‘849 patent turned on whether the claims to improvements in web-based advertising required “prefetching” an advertising object, even though these words are not set forth in the claim. The “Summary of Invention” said:

‘849 patent, 3:6-21. The “Description of the Preferred Embodiment: said:

‘849 patent, 33:16-27.

and:

‘849 patent, 34:38-44. The Federal Circuit concluded that in light of these “repeated descriptions of the present invention, a skilled artisan would understand the claimed invention requires pre-fetching of advertising objects,” citing Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007) (“When a patent . . . describes the features of the ‘present invention’ as a whole, this description limits the scope of the invention.”).

IBM tried to rely on Absolute Software, Inc. v. Stealth Signal, Inc., 659 F.3d 1121,
1136–37 (Fed. Cir. 2011), where the Federal Circuit explained that the use of the phrase “present invention” or “this invention” is not always limiting, such as where the references to a certain limitation as being the “invention’ were re not uniform, or where other portions of the intrinsic evidence do not support applying the limitation to the entire patent. However, the Federal Circuit said that these “narrow exceptions” referenced in Absolute Software were not applicable, because the ’849 patent uniformly referred to the pre-fetching of advertising objects as an aspect of the invention as a whole.

U.S. Patent No. 7,076,443 is Directed to Ineligible Subject Matter

The district court held at Alice step one the asserted claims were directed to the abstract idea of identifying advertisements based on search results. The Federal Circuit agreed, noting that it has held claims to targeted advertising were directed to an abstract idea at Alice step one. IBM argued its claims recited a specific solution to unique technical problems arising from advertising over a computer network. The Federal Circuit rejected this argument, noting that the claims were not directed to any challenges unique to computer networks, or specific improvements to the functionality of the computer itself. The claims merely recite the concept of identifying advertisements based on search results, without any specificity as to how this is accomplished. The Federal Circuit said that even accepting that the claimed invention improves the specificity and relevancy of online advertisements, this “is at most an improvement to the abstract concept of targeted advertising wherein a computer is merely used as a tool.”

Easter Lore and a Drafting Lesson

Posted on March 5, 2024 by bwheelock

You never know what tidbit you will pick up reading a patent. For example, U.S. Patent No. 6,325,691, on a Packaged Toy, is full of fun facts about the origins of Easter Traditions:

The Background of the Invention of a patent is fraught with peril for the patent drafter. First of all, you probably should use “the invention” in the heading. Define the Field of the Invention too broadly, and you invite the application of prior art that otherwise would be non-analogous. Say too much about the prior art, and you create admitted prior art. Criticize aspects of the prior art unrelated to the invention, and you may have disclaimed them. The ‘691 patent avoided most of these problems by simply recounting fun facts about Easter Traditions.

For example, did you know that in “Europe it was believed that eggs laid on Good Friday, if kept for a hundred years, would have their yolks turned into diamonds”? ‘691 Patent, Col. 1, ll. 15-17.

Did you know that the tradition of coloring Easter eggs came from the Crusades? ‘691 Patent, Col. 1, ll. 20-22.

What do you know about the history of the White House Egg Roll? It all started back on the lawn of the Capital, during the Andrew Johnson administration:

‘691 Patent, Col. 1, ll. 20-22. The ‘691 managed to avoid most of the problems that can arise from the Background Section. Happy accident, or cleverly hatched plan?

February 29, 2024 — No Leap Patents This Year

Posted on February 29, 2024 by bwheelock

Of course. today being a Thursday, no U.S. patents will issue today, A patent issuing on February 29 is a relatively rare thing. In fact, in the history of the U.S. Patent Office, only about 6787 patents have issued on February 29. Leap patents issued in 1820, 1848, 1876, 1916, 1944, 1972, and 2000. The last utility patent to issue on February 29 was U.S. Patent No. 6,032,181:

The last design patent to issue on February 29 was U.S. Patent No. D421277

There won’t be another February 29 U.S. patent until February 29, 2028.

The Attorney Knew the Applicant Abandoned Five Years Ago, But Neither He (Nor Morgan Fairchild) Knew if That is What Applicant Intended

Posted on February 27, 2024 by bwheelock

In Freshub, Inc. v. Amazon.com, Inc., [2022-1391, 2022-1425] (February 26, 2024), the Federal Circuit affirmed the jury verdict that Amazon did not infringe U.S. Patent No. 9,908,153, and the district court’s finding that it failed to prove inequitable conduct in reviving a patent application five years after it abandoned. The ’153 patent claims a voice-processing system that receives “user spoken words” and adds items to lists based on those words.

The district court found that, while the parties did not dispute the materiality of the representation that the application had been unintentionally abandoned, Amazon had not offered clear and convincing evidence that the representation was actually false—i.e., that Ikan had in fact intentionally abandoned the ’291 application. Id. at 9–10. The district court also found that, even if the representation had actually been false (i.e., even if Ikan had intentionally abandoned the application), Amazon had not offered clear and convincing evidence that the “single most reasonable inference” from the evidence, as required by Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276, 1290 (Fed. Cir. 2011) (en banc), was that either Ikan or its attorney had specifically intended to deceive the PTO with the STATEMENT in the petition to revive the application in 2017.

To prevail on the defense of inequitable conduct, the accused infringer must prove that the applicant misrepresented or omitted material information with the specific intent to deceive the PTO. The proof must be by clear and convincing evidence. Amazon asserted that the false and material statement was the denial by Ikan’s counsel that Ikan abandoned the ’291 application intentionally during the 2012–17 non-response period. The district court also found, however, that Amazon did not prove, by clear and convincing evidence, that the statement was a misrepresentation made with the required deceptive intent.

The Federal Circuit noted that it cannot disturb the district court’s rejection of the inequitable-conduct defense unless we have the definite and firm conviction that the evidence required the district court to find that Amazon proved, clearly and convincingly, that the “single most reasonable inference” from the record, was that Ikan’s counsel, when making his 2017 statement to the PTO, in fact believed that Ikan had intentionally abandoned the ’291 application for the 2012–17 period of nonresponse to the PTO. The Federal Circuit did not so find.

The Federal Circuit noted that for various reasons, including the passage of time and the limited testimonial and documentary evidence available—the latter due in part to invocations of attorney-client privilege not challenged on appeal—the record of what actually occurred at relevant times was thin. On that record, the district court found that Amazon did not clearly and convincingly prove Ikan’s intentional abandonment.

The Federal Circuit said that counsel’s statement itself can weigh in the evidentiary calculus even when it is not backed up affirmatively with a more granular and concrete account of how the five-year non-response to the PTO occurred— an account that might detail, for example, whether communications from counsel in 2012 failed to reach or inform the relevant decisionmaker at Ikan and whether years of inattention to this particular matter ensued because the attention of the company and counsel was elsewhere. Of course, the absence of such an account, due to unavailability of witnesses or invocations of attorney-client privilege or other reasons, might well lead a factfinder to find false, or even knowingly false, the assertion that the abandonment was unintentional on Ikan’s part. The Federal Circuit said the evidence clearly shows that Ikan’s counsel knew that the application had been abandoned, as he testified, but whether he made his statement with deceptive intent depends on what he believed about the subject of his statement, namely, the intent behind the abandonment. The district court could find that counsel genuinely so believed, whether or not the belief was legally correct, and that counsel did not think that Ikan had the intent to abandon during the 2012–17 non-response period. The Federal Circuit said that finding was not clearly erroneous, in light of the facts, and the district court could therefore reasonably hold deceptive intent not proven under the governing legal standard.

Happy Birthday, George Washington

Posted on February 22, 2024 by bwheelock

In the good old days, George Washington’s birthday was holiday, making February a great month for school kids, because Abraham Lincoln’s birthday was also a holiday. Two days off in the bleakest month, coupled with cupcakes on Valentine’s Day, and it was a great month to be in grade school. In addition to being celebrated by generations of school children, Inventors have celebrated George Washington many times, including in these ten patents:

U.S. Patent No. D8377 protects a Medal honoring George Washington: